MassDevice4 天
FDA medtech regulators are among latest Trump layoffs
The AP reported that the Trump administration's latest federal cuts have a significant effect on medical device regulation at ...
Med Device Online2 天
Mastering FDA Inspections: The Prep Work For Regulatory Success
In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product ...
JD Supra2 天
Health Canada Proposes Regulations to Mitigate Drug and Medical Device Shortages
Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain ...
STAT4 天
Health AI: How recent FDA layoffs could shift regulatory burden to health systems
Tech adoption might slow down if the FDA layoffs shift responsibility for medical device and AI safety to hospitals.
JD Supra3 天
Foreign Drug and Medical Device Manufacturers Under a Second Trump Administration ...
As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...
BioPharma Dive3 天
In FDA job cuts, experts see threat of far-reaching impact
"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency ...
medtechdive13 天
Former FDA head Gottlieb calls for less regulation of certain AI tools
Gottlieb, who led the FDA from 2017 to 2019, wrote that “recent changes to policies related to the regulation of AI have ...
pna4 天
FDA, Japan's PMDA strengthen ties to accelerate regulation processes
The Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) met on Tuesday to optimize the facilitated review pathway (FRP) to expedite access to essential ...
FDA Layoffs Impact Neuralink Trials and Medical Device Approvals
FDA Layoffs Shake Up Neuralink Trial Review Team. In a surprising move, the U.S. Food and Drug Administration (FDA) has laid off around 20 employees from its Office of Neurologica ...